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il y a 4 jours
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Quality Assurance
il y a 1 semaine
As a successful Quality Assurance (QA) Manager - MedTech - Belgium, you will have the following responsibilities:
- Lead the maintenance & the improvements of the QMS in compliance with 13485 & MDR/MRR
- Ensure adherence to quality standards and regulatory requirements throughout the product lifecycle
- Lead internal audits, manage external audits & support regulatory inspections
- Oversee the identification, analysis, and management of risks associated with products, processes, and operations
- Handle EMEA products complaints, CAPAs and deviations.
- Lead the Quality Assurance team and contribute to the strategic planning and direction of the QA departments
- Work collaboratively with other departments to streamline quality and compliance processes (Regulatory Affairs, supply chains, Business Units...).
- Develop and implement training programs to ensure the QA team and other relevant departments are up-to-date on the latest quality systems, regulations, and industry best practices.
As a successful Quality Assurance (QA) Manager - MedTech - Belgium, you will have the following profile:
- Master's degree in Engineering, Life Sciences, Biomedical Sciences, or a related field.
- 5+ years of experience in Quality Assurance in the medical device, biotechnology, or life sciences industry.
- Previous experience in leading a team or coaching
- Strong knowledge & experience in QMS, audits, ISO13485, MDR/MDD, regulatory requirements ...
- Strong leadership, communication, and team-building skills.
- Strong analytic & problem solving skills
- Fluent in Dutch, French & English
As a successful Quality Assurance (QA) Manager - MedTech - Belgium, you will have:
- An competitive fix salary including a bonus and a package of extra legal benefits
- The chance to join a global organization with multiple growing opportunities.
- The possibility to join a positive multicultural team contributing to the diversity and well-being of individuals all around the world.
